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Abbreviated Title: pH II Version Date: 10/11/2019Page 1 of 93BRAIN TUMOR TRIALS COLLABORATIVE (TTC) Abbreviated Title: pH II NCI Protocol #: 16C0034 Amendment Letter: B Version Date: 10/11/2019 TTC
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Obtain the necessary protocol and study materials for Phase II study.
02
Recruit participants who meet the specific criteria outlined in the protocol.
03
Conduct necessary medical tests and evaluations on participants.
04
Administer the investigational treatment according to the protocol.
05
Monitor participants closely for any adverse reactions or side effects.
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Collect and analyze data on the effectiveness and safety of the treatment.
07
Submit results to regulatory authorities for review and approval.

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01
Researchers and pharmaceutical companies looking to evaluate the safety and efficacy of a new treatment or drug.
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Patients with a specific medical condition who may benefit from participating in a clinical trial.
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Regulatory bodies and health authorities who require evidence of a treatment's effectiveness before approving it for widespread use.
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Phase II study is a clinical trial conducted to assess the safety and efficacy of a drug in a larger group of patients.
The pharmaceutical company or research institution conducting the clinical trial is required to file the phase II study.
The phase II study is filled out by including detailed information on the study design, patient population, treatment protocol, and outcomes.
The purpose of a phase II study is to further evaluate the safety and effectiveness of a drug or treatment in a larger group of patients.
The phase II study must report on the study protocol, informed consent process, adverse events, and study results.
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